At Pfizer, our purpose is to deliver breakthroughs that change patients’ lives. Your work will leverage cutting-edge design and process development capabilities to accelerate and deliver best-in-class medicines to patients globally. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, your contributions will be vital in helping Pfizer achieve new milestones and make a global impact on patient health.
What You Will Achieve
In this role, you will:
Finalize manufacturing Process and Parameters/ CPPs for Scale up, Pre Exhibit, Exhibit, Process validation batches and Commercial batches.
Prepare and review technical data, Identifying and evaluating CPPs, Stability data, Annual Product Quality Reports, Technical documents.
Coordinate with internal departments like Purchase, Analytical R&D, Production, Quality Control, Regulatory Affairs, Quality Assurance, Project Management, Engineering etc., for seamless Technology Transfer.
Plan for Technology Transfer process including various activities like procurement of API, excipients, equipment for the developmental, Optimization, Scale up, Pre Exhibit and Exhibit batches manufacturing.
Support to Regulatory Affairs for NDA/ ANDA filing activity and respond to Regulatory queries.
Prepare and review necessary guidelines/ SOPs for Developmental/ Technology Transfer activities.
Perform/execute process transfer strategies from site to site and PSci to site.
Prepare study protocols/reports for scientific studies
Stratification of data from engineering/EB/PVs for CQA trend analysis.
Technical support to Manufacturing Team for smooth launching of products.
Trouble shooting, ongoing technical support to Manufacturing team for Process validation, continuous process verification and Process improvement.
Prepare and Review of Scale up Protocols and Reports, Technology Transfer Protocols and Reports, Batch Manufacturing Records, Batch Packaging Records and Bill of Materials etc.
Ensure compliance to cGMP/ cGLP, organizations procedures and practices.
Ensure effective safety systems are implemented in the premises.
Serving as a key scientific and technical representative for process-related issues at the facility.
Partnering with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
Identifying and implementing potential process improvements in conjunction with manufacturing operations.
Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
Prepare/Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
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Here Is What You Need
(Minimum Requirements)
Ph.D./ M. Pham/M.Sc. with at least 4 years of experience
Experience in Formulation Development/Process Development/ Product Development/ Production/ Technology Transfer/Scale-up of Sterile Injectable formulations to cater regulated markets, essentially experience in Plant Technology Transfer support in Injections including process validation.
Understanding of DMAIC methodologies (M1/M2/M3)
Trained on Minitab tools/PHP/IMEx principles
Effective verbal and written communication skills
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Research and Development
